Brain Activity Study for Cognitive Impairment in Parkinson's Disease

Overseen By Isabel Long, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Age less than 40, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand the brain activity linked to memory and thinking problems in people with Parkinson's disease. Researchers will observe brain signals during deep brain stimulation surgery, which helps manage Parkinson's symptoms. Participants will receive corticosteroids, a medication that reduces inflammation. The trial seeks participants already scheduled for this surgery, who have Parkinson's disease, and can follow instructions during the procedure. As an unphased trial, participants can contribute to groundbreaking research that could enhance understanding and treatment of Parkinson's disease.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that neural recordings and stimulation are safe for studying cognitive impairment in Parkinson's disease?

Earlier studies have used deep brain stimulation (DBS) to help people with Parkinson's disease manage their symptoms. These studies have shown it to be quite safe over the mid- to long-term. For example, individuals who underwent DBS experienced improved movement and quality of life, with serious side effects being rare.

Another study tested a device that records brain activity in people with Parkinson's. This device transmitted data wirelessly and did not cause harmful side effects in the five participants who used it.

Corticosteroids, used in this study, already have FDA approval for other uses. They are generally well-tolerated but can sometimes cause side effects like higher blood sugar or mood changes.

Overall, earlier research has shown the treatments in this study to be safe. However, any treatment can have side effects, so discussing concerns with the study doctors is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to manage cognitive impairment in Parkinson's disease using neural recordings and stimulation. Unlike current treatments that primarily focus on managing motor symptoms with medications like Levodopa, this approach aims to directly influence brain activity. By recording and stimulating neural pathways, the method could offer a more targeted way to improve cognitive function, potentially leading to breakthroughs in how we understand and treat cognitive issues in Parkinson's patients.

What evidence suggests that this trial's treatments could be effective for cognitive impairment in Parkinson's disease?

Research has shown that deep brain stimulation (DBS) can help with both movement and cognitive issues in people with Parkinson's disease. Studies have found that those who receive DBS often experience better long-term outcomes than those who do not. DBS targets specific brain areas to manage symptoms, including cognitive difficulties. One study found that DBS is effective and does not worsen cognitive problems in people with advanced Parkinson's. Overall, these findings suggest that DBS could be a promising option for managing cognitive issues in Parkinson's disease. Participants in this trial will undergo neural recordings and stimulation to further explore these effects. ^{1 6 7 8 9}

Who Is on the Research Team?

Sarah Bick, MD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for English-speaking Parkinson's disease patients over 40, who are scheduled for deep brain stimulation surgery at Vanderbilt University Medical Center. Participants must be able to undergo intraoperative testing and have a clinical electrode trajectory that contacts the caudate.

Inclusion Criteria

The planned electrode path will touch the caudate.

I am 40 years old or older.

I am scheduled for deep brain stimulation surgery at Vanderbilt under local anesthesia.

Exclusion Criteria

I am unable to follow instructions or directions during surgery.

I am under 40 years old.

I have a movement disorder that is not Parkinson's disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Deep Brain Stimulation Surgery

Neural recordings from corticostriatal structures are performed during deep brain stimulation surgery to measure neural activity underlying nonmotor symptoms of Parkinson's disease

3-4 hours

Follow-up

Participants are monitored for safety and effectiveness after the surgery

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Corticosteroids

Trial Overview

The study aims to understand cognitive impairment in Parkinson's by recording brain activity from corticostriatal structures during deep brain stimulation surgery. It will measure neural activity associated with nonmotor symptoms of the disease.

How Is the Trial Designed?

Group I: Neural recordings and stimulation Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Published Research Related to This Trial

In a study of 124 non-demented Parkinson's disease patients, the type and side of initial motor symptoms did not predict the risk of later cognitive impairment, indicating that these factors may not be significant indicators of cognitive decline.

Patients with right-sided onset tremor exhibited the lowest depressive symptom scores, suggesting that this specific presentation may be associated with a reduced risk of depression compared to other motor symptom types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motor symptoms at onset of Parkinson disease and risk for cognitive impairment and depression. Dewey, RB., Taneja, A., McClintock, SM., et al.[2021]

Parkinson's disease patients with levodopa-induced dyskinesias exhibit higher impulsivity and poorer motor inhibition compared to those without dyskinesias, suggesting a link between impulsivity and motor control issues.

The study, involving 28 Parkinson's patients and a control group, found that dyskinetic patients showed slower reaction times in tasks requiring inhibition, indicating compromised inhibitory control that correlates with the severity of their involuntary movements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dysfunctional inhibitory control in Parkinson's disease patients with levodopa-induced dyskinesias. Picazio, S., Ponzo, V., Caltagirone, C., et al.[2018]

Dopamine replacement medications can have mixed effects on cognitive abilities in Parkinson's disease patients, improving some skills while potentially worsening others, depending on disease severity.

Neuroimaging studies are helping to uncover the brain changes associated with cognitive decline in Parkinson's disease, particularly as patients transition from mild cognitive impairment to dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The neurobiology and neural circuitry of cognitive changes in Parkinson's disease revealed by functional neuroimaging. Ray, NJ., Strafella, AP.[2022]

In a study of 41 patients with Parkinson's disease, cognitive impairments improved significantly at the peak of L-DOPA therapy but worsened at the end of the treatment, indicating a direct relationship between L-DOPA levels and cognitive function.

The cognitive functions most affected by L-DOPA therapy included attention, speech, executive functions, and visual-spatial abilities, suggesting that while L-DOPA helps with motor symptoms, it also has complex effects on cognitive health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Dynamics of cognitive impairments during L-dopa therapy in Parkinson's disease]. Ismailova, SB., Prokopenko, SV., Pokhabov, DV., et al.[2021]

In a study of 423 newly diagnosed Parkinson's disease patients over 3 years, cognitive impairment was found in 15-38% of participants, indicating a significant increase in cognitive decline early in the disease.

Key biomarkers predicting cognitive impairment included dopamine deficiency in specific brain regions, decreased brain volume, co-existing Alzheimer's disease pathology, and certain genetic factors, highlighting the complex neurobiological changes associated with early cognitive decline in Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple modality biomarker prediction of cognitive impairment in prospectively followed de novo Parkinson disease. Caspell-Garcia, C., Simuni, T., Tosun-Turgut, D., et al.[2023]

In a study involving 14 Parkinson's disease patients, a slower release of levodopa (CR-LD) led to improved performance on more challenging cognitive tasks, while a faster release (IR-LD) resulted in worse performance on certain tasks, indicating that the rate of levodopa absorption can significantly affect cognitive function.

The findings suggest that the timing of levodopa administration may be crucial for optimizing executive function in Parkinson's patients, particularly for tasks that require more complex working memory, although further research is needed to confirm these results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Levodopa and executive performance in Parkinson's disease: a randomized study. Pascual-Sedano, B., Kulisevsky, J., Barbanoj, M., et al.[2013]

In a study of 120 patients with idiopathic Parkinson's disease, cognitive impairment was found to be poorly correlated with motor symptoms that respond to levodopa, such as akinesia and rigidity.

Strong correlations were observed between cognitive performance and axial symptoms like gait disorder and dysarthria, which do not improve with levodopa, suggesting that cognitive issues in Parkinson's may stem from non-dopaminergic neuronal dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does cognitive impairment in Parkinson's disease result from non-dopaminergic lesions? Pillon, B., Dubois, B., Cusimano, G., et al.[2019]

In a study of 77 patients with Parkinson's disease over 4 years, only 22% showed a significant change (4 points or more) in cognitive function as measured by the Mini-Mental State Examination (MMSE) during a 2-year period.

Patients taking dopamine agonists were more likely to experience changes in their MMSE performance, suggesting that these medications may influence cognitive outcomes in Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Change in cognitive function in idiopathic Parkinson disease. Bayles, KA., Tomoeda, CK., Wood, JA., et al.[2019]

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